FREQUENTLY Asked Questions
What devices does the FDA categorize as a SaMD, and how is clinical evaluation performed?
View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Use of Software as a Medical Device is continuing to increase.  It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or "health software," and can sometimes be confused with other types of software.

During clinical evaluation of a SaMD, FDA has three main steps: valid clinical association, analytical validation, and clinical validation.

  • Valid clinical association: Ask yourself, is there a valid clinical association between your SaMD output, based on the inputs and algorithms selected, and your SaMD’s targeted clinical condition? Your first step should be to verify that the association between the SaMD output and the targeted clinical condition is supported by evidence.
  • Analytical validation: Ask yourself, does your SaMD meet technical requirements? Your first step should be to generate evidence that shows that the output of your SaMD is technically what you expected.
  • Clinical validation: Ask yourself, does your SaMD generate clinically relevant outputs? Your first step should be to generate evidence that shows your:
    (1) SaMD has been tested in your target population and for your intended use; and that
    (2) Users can achieve clinically meaningful outcomes through predictable and reliable use.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST